MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-19 for XTRA SILENT NITE manufactured by Prismatik Dentalcraft, Inc..
[139256422]
Patient's weight and date of event were asked but unknown. The device was received and the evaluation is anticipated. Once the investigation is completed, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[139256423]
It was reported that a patient experienced an allergic reaction after using the xtra silent nite night guard. The patient's tissue was inflamed on the inside of her lower lip and on the gingival facial tissue of the lower anterior teeth. The patient reported the symptom to the office a month after the night guard was delivered; however, it was unknown when she first developed the symptom. It was not known how long the symptom lasted after the patient stopped using the night guard. The patient did not require any treatment for the reaction. The patient has no known pre-existing condition or known allergy. The doctor did not make any adjustment to the night guard prior delivering it to the patient. The night guard was also rinsed with water before delivering to the patient. It was not known how the patient cleaned the night guard.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00047 |
| MDR Report Key | 8434301 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-19 |
| Date of Report | 2019-06-19 |
| Date Mfgr Received | 2019-06-19 |
| Device Manufacturer Date | 2018-10-22 |
| Date Added to Maude | 2019-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TOAN HOANG |
| Manufacturer Street | 2212 DUPONT DRIVE SUITE P |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal | 92612 |
| Manufacturer Phone | 9492251235 |
| Manufacturer G1 | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Street | 2212 DUPONT DRIVE SUITE P |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92612 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XTRA SILENT NITE |
| Generic Name | ANTI-SNORING NIGHTGUARD |
| Product Code | LRK |
| Date Received | 2019-03-19 |
| Returned To Mfg | 2019-03-08 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Address | 2212 DUPONT DRIVE SUITE P IRVINE CA 92612 US 92612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-19 |